KQ

Kelly Quesada

Senior Vice President at Oxford Biomedica Solutions

Kelly Quesada's work experience is as follows:

1. Oxford Biomedica Solutions (2022 - Present)

- Senior Vice President responsible for Strategy, Program Management, Legal, IT, Quality, and Regulatory functions.

- Partnered with CEO on a $180 million deal that led to the formation of the Oxford Biomedica Solutions joint venture and built out G&A functions.

- Promoted from Vice President in July 2022.

2. Chief (2022 - Present)

- Member of the company.

3. Homology Medicines, Inc. (2018 - 2022)

- Vice President, Head of Quality (2020 - 2022)

- Built Quality organization, including Quality Assurance, Quality Control, Quality Systems, and Validation.

- Implemented GxP Quality Systems to meet regulatory requirements and ensure safety and quality of AAV gene therapy and gene editing products.

- Senior Director, Head of Quality (2018 - 2020)

- First Quality hire for Homology Medicines, Inc.

- Built Quality organization, including Quality Assurance, Quality Control, Quality Systems, and Validation.

- Implemented GxP Quality Systems to meet regulatory requirements and ensure safety and quality of AAV gene therapy and gene editing products.

4. Shire (2015 - 2018)

- Head of Global Supplier Quality Management (2016 - 2018)

- Led organization of 27 quality professionals across 11 global locations with responsibility for supplier quality management of 3,000 GMP/GDP suppliers.

- Integrated Supplier Quality Management program post major acquisition six months ahead of schedule.

- Led internal audit team responsible for GMP/GDP audits of over 60 Shire entities.

- Head of QA Engineering (2015 - 2016)

5. Amgen (2003 - 2014)

- Senior Manager - International Quality (2011 - 2014)

- Served as Quality Lead, responsible for product transfers/launches into Asia markets.

- Built quality system infrastructure that met local regulatory requirements, policies, standards, and procedures.

- Senior Manager - Equipment Validation (2007 - 2011)

- Leader of a team that supported the validation of facilities, utilities, and equipment.

- Responsible for the Validation program, including periodic monitoring and maintenance of procedures and master plans.

- Manager - Quality Control/Warehouse Validation (2005 - 2007)

- Validation Engineer - Quality Control/Warehouse Validation (2003 - 2005)

6. Baxter BioScience (1999 - 2003)

- Supervisor.

Kelly Quesada attended UCLA, but there is no information provided regarding the start and end years, degree obtained, or field of study.

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